| Greetings!
AAPS Pharma is pleased to announce an upcoming workshop focused on Computer System Validation (CSV), a crucial regulatory requirement for the healthcare industry. Mandated by Health Canada, the FDA, and the European Union, CSV ensures that all computerized systems or automated data processing systems in healthcare (including pharmaceuticals, medical devices, logistics, and warehousing) are validated for their intended use according to pre-defined protocols before being put into production. This workshop provides a comprehensive introduction to CSV and its regulations, offering participants the foundational knowledge required for day-to-day operations in regulated industries.
Throughout the workshop, participants will gain valuable insights into the principles of CSV, including an in-depth exploration of GAMP®5 and the critical role it plays in system categorization. Key topics include the System Development Life Cycle (SDLC), the V-Model Approach, and the essential validation deliverables such as requirements documents, validation plans, and test reports. Additionally, the workshop will cover 21 CFR Part 11 compliance and the regulatory landscape surrounding CSV in both the FDA and international markets. Through practical application and real-world case studies, attendees will learn the competencies needed to ensure efficient, effective, and inspection-ready validation initiatives.
This workshop is ideal for professionals in the healthcare industry responsible for the validation of computerized systems. It is particularly beneficial for those in quality assurance, regulatory affairs, IT, validation engineering, and compliance roles. It also offers immense value to individuals involved in developing, implementing, or overseeing validation protocols and procedures. By the end of the session, participants will have a deep understanding of the regulatory requirements surrounding CSV, the SDLC, and best practices for validation deliverables, all while ensuring ongoing audit readiness and compliance.
Join us to gain the expertise required to navigate the complexities of computer system validation and ensure your systems remain compliant with the latest regulatory standards. | 
